The Superior Council of Infectious Diseases issues a new opinion on the conditions of administration of AstraZeneca's Vaxzevria vaccine against COVID-19

In its opinion of 16 April, the Superior Council of Infectious Diseases (Conseil supérieur des maladies infectieuses - CSMI) takes a position on the conditions of administration of the AstraZeneca vaccine, now called Vaxzevria, in the light of the recent opinion of the European Medicines Agency (EMA) on the subject and the restrictions on its use according to age, decided by Germany (60 years), France (55 years), Belgium (between 50 and 60 years, depending on the availability of alternative vaccines), and the United Kingdom (30 years) in recent days. ​

It should be noted that on 7 April, the EMA concluded that there was a possible link between the administration of Vaxzevria vaccine and unusual thrombosis associated with thrombocytopenia within 2 weeks of the vaccine administration. The EMA has clarified that these unusual thromboses are a very rare side effect of the vaccine and that the benefit of the vaccine continues to outweigh any risks.

The CSMI recommends in this opinion, as a precautionary measure, on a temporary basis and pending further data on the safety of this vaccine:

  • "to continue the use of Vaxzevria for the vaccination of all persons aged 55 years and over;
  • to suspend the use of Vaxzevria for vaccination
    • of people under 30 years of age, with or without vulnerability criteria,
    • of people aged 30-54 with no vulnerability criteria;
  • give preference to vaccination of persons aged 30-54 years with criteria of vulnerability to COVID-19 due to a pre-existing health condition (phases 2b, 3b, 4b and 5b) with an mRNA vaccine (Comirnaty or Moderna). For this age group however, because of the importance of rolling out vaccination and achieving the widest possible coverage as soon as possible, vaccination with Vaxzevria should be offered as an alternative vaccine in the absence of other products;
  • to vaccinate pregnant women with an mRNA vaccine (as previously recommended)."

The CSMI did not decide on the use of an mRNA vaccine (Comirnaty, Moderna) for the 2nd dose after a 1st dose of Vaxzevria, due to lack of scientific data.

The Government Council decided to follow the opinion of the CSMI in application of the precautionary principle. People aged between 30 and 54 will have the opportunity to register on a list and express their interest in being voluntarily vaccinated with Vaxzevria. People on this list, which will be opened during the week of 19 April, will receive an invitation depending on the date of registration and the availability of the Vaxzevria vaccine.

The government has decided not to follow the CSMI's recommendation to administer the 2nd dose of Vaxzevria vaccine at an interval of 12 weeks after the 1st dose. The 10-week interval between the two doses will therefore be maintained.

Vaccine efficacy studies in relation to AstraZeneca's product are continuing and further statements from the EMA are expected in the week of 19 April. The government will communicate in due course.

The opinion of the CSMI is subject to change in the light of the development of new data on vaccine safety, the availability and characteristics of vaccines and epidemiological developments in Luxembourg.

 

Press release by the Ministry of Health / Ministry of State

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